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Completed

NCT Number: NCT03167125

Participatory Research to Advance Colon Cancer Prevention

The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases.

In Phase I (Years 01 - 02), the investigators will tailor and define intervention components using a community-based participatory research approach called boot camp translation (BCT). The ultimate design of the intervention will be defined by patient and provider feedback from BCT. The investigators will then conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated phone calls, text messages) to alert and remind patients to complete screening, 2) live prompts (i.e., live phone calls), and 3) a combination approach of automated plus live prompts.

In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted intervention to additional clinics within the partnering health center using a two-arm main trial.

Both phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AltaMed Health Services

Los Angeles, California, 90040, United States

About this study

The study will fulfill the following aims:

Aim 1: Develop personalized messages (e.g., phone scripts, text messages, patient portal prompts) and define an intervention using boot camp translation to increase colon cancer screening among Latino populations.

Aim 2: Assess the reach, effectiveness, and differences by subgroup (e.g., preferred language) of a three-arm colorectal cancer screening program among Latino FQHC patients, in 2 clinics, through a patient randomized-controlled trial.

In addition to Usual Care, the arms are:

  • Automated Prompts-an automated data-driven program for delivering FIT kit prompts (using automated phone calls, text messages, and/or emails) to patients due for colorectal cancer screening.
  • Automated Plus Live Prompts-a higher-intensity program using automated, data-driven strategies for delivering FIT kit prompts plus linguistically and culturally tailored live prompts.

Aim 3: Test the spread of the program across additional clinics using a two-arm randomized approach and develop an implementation guide that includes outreach materials, strategies for incorporating patient input, and resources.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons aged 50-75 years and not up-to-date with colorectal cancer screening

Exclusion criteria

  • Persons having colorectal disease (e.g., ulcerative colitis or colectomy), personal history of colorectal cancer or colorectal disease, end-stage or life threatening diseases or, those known to be under hospice care or living in a skilled nursing facility may be excluded.

Treatment and study plan

Automated Prompts

Other

This intervention is an automated data-driven program, using automated phone calls, text messages, and/or emails, for delivering FIT kit prompts to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.

Automated Plus Live Prompts

Other

This intervention is a higher-intensity program, using automated data-driven prompts plus linguistically and culturally tailored live prompts, for delivering FIT kit messages to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.

Primary outcomes

  1. Increased colorectal cancer screening rates

    Time frame: Up to 4 years (study period)

    Fecal testing completion

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • AltaMed Health Services Corporation
  • Oregon Health and Science University

Registry information

Acronym: PROMPT

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
May 25, 2017
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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